MAUDE Adverse Event Report: ARTHREX, INC. APSII FOOTSWITCH, STANDARD; POWERED SURG ORTHOPEDIC INSTR

Model Number	APSII FOOTSWITCH, STANDARD
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/09/2023, it was reported by a sales representative via sems that an ar-8310 footswitch cables are damaged and exposed.This was discovered during a case with no patient effect.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint is confirmed.Functional testing was not performed due to the exposed wires.Visual evaluation noticed that the device was damaged.The most likely cause of this condition is user error.

• Brand Name: APSII FOOTSWITCH, STANDARD
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 17697479
• Report Number: 1220246-2023-07791
• Device Sequence Number: 7399338
• Product Code: HWE
• UDI-Device Identifier: 00888867043145
• UDI-Public: 00888867043145
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K932699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: APSII FOOTSWITCH, STANDARD
• Device Catalogue Number: AR-8310
• Device Lot Number: 401596
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown